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Ground-breaking Federal District Court Ruling on Gene Patents

In Association for Molecular Pathology et al. v. United States Patent And Trademark Office et al.1, Association for Molecular Pathology and other plaintiffs, including some physicians and cancer patients, asked a federal district court in New York, in a motion for summary judgment, to invalidate several so-called “gene patents” owned by the University of Utah and Myriad Genetics. The patents are directed to two isolated gene sequences, BRCA1 and BRCA2, that researchers had discovered to be correlated with a heightened susceptibility to breast cancer. In addition to composition claims directed to the isolated genes, the patents also include method claims for analyzing BRCA1 and BRCA2 genes (or RNA) extracted from an individual to identify the presence of mutations, if any, in those genes as well as for determining the individual’s predisposition to breast cancer based on the mutations.

Judge Robert Sweet granted the motion of summary judgment and concluded that the composition claims as well as the method claims were not eligible for patenting and hence were invalid. The judge relied, at least in part, on a Supreme Court decision from 1931, American Fruit Growers, Inc. v. Brodgex Co.2, to invalidate the composition claims. In that case, the Supreme Court had held that oranges whose skin had been treated with mold-resistant borax had not been sufficiently transformed into a new and different article to be eligible for patenting. Similarly, Judge Sweet held that isolated DNA did not possess “markedly different characteristics” from its naturally occurring counterpart to be eligible for patenting.

Judge Sweet relied on the recent case of In re Bilski3, which is presently before the U.S. Supreme Court, to invalidate the method claims. In In re Bilski, the U.S. Court of Appeals for the Federal Circuit held that a method claim is patent eligible if (1) it is sufficiently tied to a particualr machine or apparatus or (2) it transfoms an article into a different state or thing. Though this “machine-or-transformation” test was enunciated in the context of a so-called “business method” patent that was directed to a method of hedging risks in commodity trading, it has been applied post-Bilski by a number of courts to medical diagnostic methods.

In this case, the defendants relied on a recent post-Bilski case, Prometheus Laboratories, Inc. v. Mayo Collaborateive Services4, to argue that the steps of “analyzing” and “comparing” recited in the method claims were transformative. In Prometheus, the Federal Circuit had held that the step of “determining the levels of metabolites” in a method claim directed to adjusting the dosage level of certain therapeutic drugs, in order to enhance efficacy and minimize side effects, was transformative as it involved extraction and measurement of metabolite concentrations, e.g., via high pressure liquid chromatography. Judge Sweet, however, did not agree and held that the steps of “analyzing” and “comparing” were merely mental steps. The judge went even further and indicated that even if the challenged claims “were read to include the transformations associated with isolating and sequencing human DNA,” these transformations would not render the claims patent eligible as they would be merely what Bilski characterizes as “data gathering step[s]” that are not “central to the purpose of the claimed process.”

The Federal Circuit is likely to grant certiorari on this case. Look for continued updates on this important case, as well as the Supreme Court’s upcoming decision in Bilski, in future issues of Nutter’s IP Bulletin.

This advisory was prepared by Nutter's Intellectual Property practice. For more information, please contact your Nutter attorney at 617-439-2000.

This update is for information purposes only and should not be construed as legal advice on any specific facts or circumstances. Under the rules of the Supreme Judicial Court of Massachusetts, this material may be considered advertising.